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National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem-Cell (MSC) Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patients - Phase-III Trial

ConditionAcute-On-Chronic Liver Failure
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially mesenchymal stem cells (MSCs), shows promise but lacks validation, particularly for non-viral ACLF. The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ACLF patients with Model for End-Stage Liver Disease (MELD) score >18 or APASL ACLF Research Consortium (AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant.

Disqualifiers

Age <18 or >65 yrs

Patients with active sepsis

Patients with Hepatic Venous Outflow Tract Obstruction(HVOTO) or Extrahepatic Portal Vein Obstruction (EHPVO)

Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Umbilical cord Mesenchymal stem cell

    Drug

    ucMSC 1 million/kg will be given once a week for 4 week . 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. The fresh ucMSCs will then be infused through IV canula peripherally over 30 minutes followed by a further 250 ml normal saline over 20-30 minutes.

  • Steroid

    Drug

    Prednisolone 40 mg once daily for 7 days as inpatients. After that Lille score will be calculated on day 7. Responders (Lille score \< 0.45) will be continued on steroids for a total of 4 weeks, followed by 2 weeks oftapering before stopping the therapy. In patients who were non responsive to steroids (Lille score \> 0.45) at day 7, steroids will be stopped at day 7 and will receive only SMT.

  • Standard Medical Treatment

    Other intervention

    All patients will receive the standard medical treatment.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Umbilical cord Mesenchymal stem cell (ucMSC) and standard medical treatment (SMT)Experimental treatment 2 interventions
Group B: Steroid and Standard medical treatmentActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

90-day transplant-free survival

Time frame
Day 90

Secondary outcomes

1

28-day and 6-month transplant free survival

Time frame
28-day and 6-month
2

Cumulative incidence of acute kidney injury (AKI), sepsis and extrahepatic-extrarenal organ dysfunctions day 28, day 60 and day 90.

Time frame
Day 28, day 60 and day 90
3

Proportion of patients achieving resolution of ACLF (complete and partial) at day 90.

Time frame
Day 90
4

Improvement in liver severity indices model for End-stage liver disease (MELD) score by 4 points and improvement in APASL ACLF Research Consortium (AARC) grade by 1 from baseline at 28 days, day 60 and day 90.

Time frame
28 days, day 60 and day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Liver and Biliary Sciences, India

Lead sponsor

Indian Council of Medical Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: